Label: JERGENS NATURAL GLOW FACE MOISTURIZER MEDIUM TO DEEP SKIN TONES- avobenzone,octisalate, octocrylene lotion
- NDC Code(s): 10596-718-20
- Packager: Kao USA 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 June 27, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
For sunscreen use:- apply generously and evenly to freshly cleansed face, avoiding eyebrows, 15 minutes before sun exposure
- wash hands after application
- reapply at least every 2 hours*
- use a water resistant sunscreen if swimming or sweating
- children under 6 months of age: Ask a doctor
- 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:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients
Water, Dihydroxyacetone, Glycerin, Aluminum Starch Octenylsuccinate, Dicaprylyl Ether, Glyceryl Stearate, Polyacrylamide, Behebyk Alcohol, C12-15 Akyl Benzoate, Dimethicone, Phenyl Trimethicone, PEG-100 Stearate, C13-14 Isoparaffin, Erythrylose, Cetyl Alcohol, Diethylhexyl 2,6 Naphthalate, Steareth-2, Fragrance, Xanthan Gum, Laureth-7, Citric Acid, Fragrance, Tocopheryl Acetate, Zea Mays (Corn) Starch, Methylparaben, Ethylparaben, Propylparaben, Caramel
- QUESTIONS
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SPL UNCLASSIFIED SECTION
How to Use to get Natural-Looking Color: For best results, use daily as your facial moisturizer. Apply a generous amount evenly over freshly cleansed face, blending into jawline & hairline and avoiding eyebrows. Allow several minutes for it to fully absorb. Wash your hands after application. You will begin to see development of color within several days with no sunless tanner odor. If color change is not as noticeable as desired, apply more frequently.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JERGENS NATURAL GLOW FACE MOISTURIZER MEDIUM TO DEEP SKIN TONES
avobenzone,octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10596-718 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.74 g in 59 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.95 g in 59 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.65 g in 59 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) STARCH, CORN (UNII: O8232NY3SJ) DIHYDROXYACETONE (UNII: O10DDW6JOO) CETYL ALCOHOL (UNII: 936JST6JCN) DICAPRYLYL ETHER (UNII: 77JZM5516Z) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DOCOSANOL (UNII: 9G1OE216XY) DIMETHICONE (UNII: 92RU3N3Y1O) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-100 STEARATE (UNII: YD01N1999R) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) STEARETH-2 (UNII: V56DFE46J5) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) ETHYLPARABEN (UNII: 14255EXE39) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) PROPYLPARABEN (UNII: Z8IX2SC1OH) XANTHAN GUM (UNII: TTV12P4NEE) LAURETH-7 (UNII: Z95S6G8201) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) L-ERYTHRULOSE (UNII: WKK1W5B83O) CARAMEL (UNII: T9D99G2B1R) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10596-718-20 1 in 1 BOX 06/27/2023 1 59 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/27/2023 Labeler - Kao USA Inc. (004251617)