Label: SURFERS SKIN SUNSCREEN- octinoxate, oxybenzone, titanium dioxide, zinc oxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 75916-4019-1, 75916-4019-4 - Packager: Skin Alive, Ltd.
- Category: HUMAN OTC DRUG LABEL
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 31, 2011
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive Ingredients
-
DESCRIPTION
Surfersskin SPF 30+ Sunscreen, VERY WATER/SWEAT RESISTANT, BROAD SPECTRUM, UVA/UVB PROTECTION. keep your "Skin Alive" with this non greasy sweat resistant formula that won't runinto your eyes and give you up to 80 mins protection in the water.
Made in NZ
Skin alive
Expires:
Lot Numberwww.surfersskin.co
DIST. BY: Quiver Dist., Bend Oregon, USA 97701
AS/ANZ STANDARD 2604-1998
4.2 fl oz (125ml)
To report a serious adverse event, contact 1-800-332-1088
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SURFERS SKIN SUNSCREEN
octinoxate, oxybenzone, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75916-4019 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3.45 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1 mL in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.95 mL in 100 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:75916-4019-4 125 mL in 1 TUBE 2 NDC:75916-4019-1 1 in 1 BOX 2 40 mL in 1 TUBE 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)