TAYLOR JAMES, LTD.
4
UNSEEN SUNSCREEN BROAD SPECTRUM SPF 40- avobenzone, homosalate, octinoxate, octisalate cream TAYLOR JAMES, LTD. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Unseen Sunscreen Broad Spectrum SPF 40 Active Ingredients Purpose Avobenzone 3% Sunscreen Homosalate 8% Sunscreen Octinoxate 4.5% Sunscreen Octisalate 5% Sunscreen Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if rash occurs Warnings For external use only Do not use on damaged or broken skin Directions apply generously and evenly 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m.-2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months: ask a doctor Inactive Ingredients Isododecane, Dimethicone Crosspolymer, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Isohexadecane, Dicrapylyl Carbonate, Meadowfoam Estolide, Polyester-8,Polymethylsilsesquioxane, Caprylic/Capric Triglyceride, Lithothamnion Calcareum Extract,Butyrospermum Parkii (Shea) Butter, Jojoba Esters, Diethylhexyl Syringylidenemalonate, Mannitol, Olibanum, Lecithin, Microcrystalline Cellulose, Diatomaceous Earth, Zinc Sulfate, Silica, Tocopherol Unseen Sunscreen
Transcript of TAYLOR JAMES, LTD.
UNSEEN SUNSCREEN BROAD SPECTRUM SPF 40- avobenzone, homosalate, octinoxate,octisalate cream TAYLOR JAMES, LTD.Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
Unseen Sunscreen Broad Spectrum SPF 40Active Ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 8% Sunscreen
Octinoxate 4.5% Sunscreen
Octisalate 5% Sunscreen
UsesHelps prevent sunburnIf used as directed with other sun protection measures (see Directions ), decreases the risk of skincancer and early skin aging caused by the sun
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison ControlCenter right away.
Stop use and ask a doctor if rash occurs
WarningsFor external use onlyDo not use on damaged or broken skin
Directionsapply generously and evenly 15 minutes before sun exposurereapply:
after 40 minutes of swimming or sweating
immediately after towel drying
at least every 2 hoursSun Protection Measures Spending time in the sun increases your risk of skin cancer and early skinaging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 orhigher and other sun protection measures including:Limit time in the sun, especially from 10 a.m.-2 p.m.Wear long-sleeved shirts, pants, hats, and sunglassesChildren under 6 months: ask a doctor
Inactive Ingredients
Isododecane, Dimethicone Crosspolymer, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer,Isohexadecane, Dicrapylyl Carbonate, Meadowfoam Estolide, Polyester-8,Polymethylsilsesquioxane,Caprylic/Capric Triglyceride, Lithothamnion Calcareum Extract,Butyrospermum Parkii (Shea) Butter,Jojoba Esters, Diethylhexyl Syringylidenemalonate, Mannitol, Olibanum, Lecithin, MicrocrystallineCellulose, Diatomaceous Earth, Zinc Sulfate, Silica, Tocopherol
Unseen Sunscreen
Broad Spectrum SPF 40
Water and sweat resistant (40 minutes)
1.7 fl oz/ 50 ml
UNSEEN SUNSCREEN BROAD SPECTRUM SPF 40 avobenzone, homosalate, octinoxate, octisalate cream
Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:759 36 -142
Route of Adminis tration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX) AVOBENZONE 3 g in 10 0 mL
HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S) HOMOSALATE 8 g in 10 0 mL
O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4.5 g in 10 0 mL
O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W) OCTISALATE 5 g in 10 0 mL
TAYLOR JAMES, LTD.
Inactive IngredientsIngredient Name Strength
ISO DO DECANE (UNII: A8 28 9 P6 8 Y2)
DIMETHICO NE CRO SSPO LYMER ( 4 50 0 0 0 MPA.S AT 12 % IN CYCLO PENTASILO XANE) (UNII: UF76 20 L1W6 )
DIMETHICO NE/BIS-ISO BUTYL PPG-2 0 CRO SSPO LYMER (UNII: O4I3UFO6 ZF)
ISO HEXADECANE (UNII: 9 18 X1OUF1E)
DICAPRYLYL CARBO NATE (UNII: 6 0 9 A3V1SUA)
PO LYESTER-8 ( 14 0 0 MW, CYANO DIPHENYLPRO PENO YL CAPPED) (UNII: T9 29 6 U138 P)
PO LYMETHYLSILSESQ UIO XANE ( 11 MICRO NS) (UNII: Z570 VEV8 XK)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)
PHYMATO LITHO N CALCAREUM (UNII: 6 J1M3WA0 ZK)
SHEA BUTTER (UNII: K49 155WL9 Y)
DIETHYLHEXYL SYRINGYLIDENEMALO NATE (UNII: 3V5U9 7P248 )
MANNITO L (UNII: 3OWL53L36 A)
FRANKINCENSE (UNII: R9 XLF1R1WM)
LECITHIN, SUNFLO WER (UNII: 8 34K0 WOS5G)
MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)
DIATO MACEO US EARTH (UNII: 2RF6 EJ0 M8 5)
ZINC SULFATE (UNII: 8 9 DS0 H9 6 TB)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
TO CO PHERO L (UNII: R0 ZB2556 P8 )
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:759 36 -142-0 2 1 in 1 CARTON 10 /12/20 17
1 NDC:759 36 -142-0 1 50 mL in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct
2 NDC:759 36 -142-0 6 15 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct 10 /12/20 17
3 NDC:759 36 -142-0 3 10 mL in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct 10 /12/20 17
4 NDC:759 36 -142-0 4 5 mL in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct 10 /12/20 17
5 NDC:759 36 -142-0 5 1.5 mL in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct 10 /12/20 17
6 NDC:759 36 -142-0 7 20 mL in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph fina l part352 10 /10 /20 17
Labeler - T AYLOR JAMES, LT D. (033381850)
EstablishmentName Addre ss ID/FEI Bus ine ss Ope rations
Co sway Co mpany Inc . 0 5240 0 223 manufacture(759 36 -142)
Revised: 1/2021
