Label: LIGHT BEAM HAND REPAIR CREAM BROAD SPECTRUM SPF 18- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4082-1, 62742-4082-2 - Packager: Allure Labs, 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 April 28, 2016
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
For sunscreen use:
- Apply liberally 15 minutes before sun exposer.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- Children under 6 months: 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 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 sleeve shirts, pants, hats and sunglasses.
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INACTIVE INGREDIENT
Water, Caprylic/Capric Triglycerides, Glycerin, Polysorbate 60, Butyrospermum Parkii (Shea) Butter, Pleurotus Sajor-caju Ferment Filtrate, Stearic Acid, Sorbitan Stearate, Cetearyl Glucoside, Cetyl Alcohol, Hippophae Rhamnoides oil, Bakuchiol, Dipotassium Glycyrrhizate, Camellia Sinensis Leaf Extract, Allantoin, Cross Nucifera (Cococnut) Oil, Xanthan Gum, Tocopheryl Acetate, Isostearic Acid, Stearyl Alcohol, Lecithin, Polyhydroxystearic Acid, Polyglyceryl-3 Ricinoleate, Carrageenan, Fragrance, Phenoxyethanol, Ethylhexylglycerin, Titanium Dioxide, Mica, Silica.
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIGHT BEAM HAND REPAIR CREAM BROAD SPECTRUM SPF 18
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4082 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9.45 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 60 (UNII: CAL22UVI4M) SHEA BUTTER (UNII: K49155WL9Y) STEARIC ACID (UNII: 4ELV7Z65AP) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETYL ALCOHOL (UNII: 936JST6JCN) HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J) BAKUCHIOL (UNII: OT12HJU3AR) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ALLANTOIN (UNII: 344S277G0Z) COCONUT OIL (UNII: Q9L0O73W7L) XANTHAN GUM (UNII: TTV12P4NEE) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ISOSTEARIC ACID (UNII: X33R8U0062) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) CARRAGEENAN (UNII: 5C69YCD2YJ) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICA (UNII: V8A1AW0880) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4082-2 1 in 1 CARTON 04/28/2016 1 NDC:62742-4082-1 60 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 final part352 04/28/2016 Labeler - Allure Labs, Inc (926831603)
