Label: GENTLE REJUVENATION FORTIFIED SUNSCREEN BROAD SPECTRUM SPF 30 WITH VITAMIN C- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62032-130-70 - Packager: Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC.
- 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 December 19, 2017
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
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- helps prevent sunburn
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- 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
- Warnings
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Directions
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- apply liberally 15 minutes before sun exposure
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- use a water resistant sunscreen if swimming or sweating
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- reapply at least every 2 hours
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- children under 6 months: Ask a doctor
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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 a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
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- limit time in the sun, especially from 10 a.m.–2 p.m.
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- wear long-sleeved shirts, pants, hats, and sunglasses
- Inactive ingredients
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 48 g Tube Carton
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INGREDIENTS AND APPEARANCE
GENTLE REJUVENATION FORTIFIED SUNSCREEN BROAD SPECTRUM SPF 30 WITH VITAMIN C
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-130 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 80 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 27.9 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg in 1 g Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6) DIMETHICONE (UNII: 92RU3N3Y1O) OCTOXYNOL-9 (UNII: 7JPC6Y25QS) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-130-70 48 g in 1 BOTTLE; Type 0: Not a Combination Product 11/04/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/04/2013 Labeler - Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC. (790553353) Establishment Name Address ID/FEI Business Operations Swiss-American CDMO, LLC 080170933 MANUFACTURE(62032-130) , LABEL(62032-130) , PACK(62032-130)
