Label: BRIGHT GUARD SPORT SPF- zinc spf lotion
- NDC Code(s): 76348-675-01
- Packager: RENU LABORATORIES, INC.
- 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 July 1, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- STATEMENT OF IDENTITY
- Active Ingredients
- Purpose
- USES
-
WARNINGS
- For external use only.
- Do not use on damaged or broken skin.
- When using this product keep out of eyes. Rinse with water to remove.
- Stop use and consult physician if irritation or rash develops.
- Keep out of reach of children.
- If product is swallowed, get medical attention or contact poison control center immediately.
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DIRECTIONS
- Apply generously 15 minutes before sun exposure
- Reapply after 80 minutes of swimming or sweating.
- reapply immediately after towel drying.
- Reapply 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 sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including
- Limited time in the sun, especially between 10am and 2pm.
- Wear long sleeve shirts, pants, hats and sunglasses.
- For children under 6 months, consult a physician.
- OTHER INGREDIENTS
- Other information
- Questions or Comments?
- Pouch Label
-
INGREDIENTS AND APPEARANCE
BRIGHT GUARD SPORT SPF
zinc spf lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-675 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17.5 g in 1000 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 70 g in 1000 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 10 g in 1000 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 12.5 g in 1000 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHICONE 350 (UNII: 2Y53S6ATLU) CETYL ALCOHOL (UNII: 936JST6JCN) CARBOMER 934 (UNII: Z135WT9208) WATER (UNII: 059QF0KO0R) ISOCETYL STEARATE (UNII: 3RJ7186O9W) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYESTER-7 (UNII: 0841698D2F) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXYLENE GLYCOL (UNII: KEH0A3F75J) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-675-01 1000 g in 1 POUCH; Type 0: Not a Combination Product 07/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/01/2021 Labeler - RENU LABORATORIES, INC. (945739449) Registrant - RENU LABORATORIES, INC. (945739449) Establishment Name Address ID/FEI Business Operations RENU LABORATORIES, INC. 945739449 manufacture(76348-675)
