Label: GOLFERS SKIN BROAD SPECTRUM SPF 30 PLUS SUNSCREEN- octinoxate, oxybenzone, titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 75916-4020-1, 75916-4020-2, 75916-4020-3, 75916-4020-4, view more75916-4020-5 - Packager: Skin Alive, Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 13, 2015
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- Official Label (Printer Friendly)
- Golfers Skin Broad Spectrum SPF 30+ Sunscreen
- Active Ingredients
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
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Directions
Apply generously 15 mins before sun exposure.
Reapply:
* After 40 minutes of swimming or sweating.
* Immediately after towel drying
* At least every 2 hours
Sun Protections Measure. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use and sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
* Limit time in the sun, especially from 10am-2pm
* Wear long-sleeve shirts, pants, hats and sunglasses
* Children under 6 months: Ask a Doctor
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
- Representative Product Labeling
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INGREDIENTS AND APPEARANCE
GOLFERS SKIN BROAD SPECTRUM SPF 30 PLUS SUNSCREEN
octinoxate, oxybenzone, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75916-4020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 34.5 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 10 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 19.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CYCLOMETHICONE (UNII: NMQ347994Z) WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 60 (UNII: CAL22UVI4M) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HONEY (UNII: Y9H1V576FH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75916-4020-4 125 mL in 1 TUBE 2 NDC:75916-4020-1 1 in 1 BOX 2 40 mL in 1 TUBE 3 NDC:75916-4020-3 1000 mL in 1 BOTTLE 4 NDC:75916-4020-5 2000 mL in 1 BOTTLE 5 NDC:75916-4020-2 5 mL in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/31/2011 Labeler - Skin Alive, Ltd. (593384746) Registrant - Skin Alive, Ltd. (593384746)