Label: BRIGHT GUARD NATURAL SPF 30- zinc oxide lotion
- NDC Code(s): 76348-676-01
- Packager: Renu Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 August 24, 2022
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- STATEMENT OF IDENTITY
- ACTIVE INGREDIENT
- Purpose
- INDICATIONS & USAGE
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WARNINGS
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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DOSAGE & ADMINISTRATION
DIRECTIONS:
- Apply liberally 15 minutes before sun exposure
- Reapply at least every two hours and
- Immediately after swimming, sweating or towel drying
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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
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INACTIVE INGREDIENT
OTHER INGREDIENTS:
Cananga Odorata (Ylang Ylang) Flower Oil, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Olivate, Coco Caprylate, Deionized Water, Fragrance, Hexylene Glycol, Panthenol, Phenoxyethanol, Polyhydroxystearic Acid, Silica, Sodium Phytate, Sorbitan Olivate, Stearyl/Octyldodecyl Citrate Crosspolymer, Styrene / Acrylates Copolymer, Tocopherol, Xanthan Gum
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BRIGHT GUARD NATURAL SPF 30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-676 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 209 g in 950 g Inactive Ingredients Ingredient Name Strength PHYTATE SODIUM (UNII: 88496G1ERL) XANTHAN GUM (UNII: TTV12P4NEE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PANTHENOL (UNII: WV9CM0O67Z) WATER (UNII: 059QF0KO0R) YLANG-YLANG OIL (UNII: 8YOY78GNNX) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXYLENE GLYCOL (UNII: KEH0A3F75J) COCO-CAPRYLATE (UNII: 4828G836N6) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-676-01 950 g in 1 POUCH; Type 0: Not a Combination Product 08/24/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 08/24/2022 Labeler - Renu Laboratories, Inc. (945739449) Establishment Name Address ID/FEI Business Operations Renu Laboratories, Inc. 945739449 manufacture(76348-676)
