Label: DAILY SPF PRIMER SPF 50- zinc oxide lotion
- NDC Code(s): 81545-102-40
- Packager: Lee Indie & Co Inc
- Category: HUMAN OTC DRUG LABEL
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 January 6, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
- Apply liberally before sun exposure.
- Reapply:
- Use a water-resistant sunscreen if swimming or sweating
- 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 a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit your time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months of age: ask a doctor.
-
INACTIVE INGREDIENTS
Water, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Jojoba Esters, Propanediol, Tridecyl Salicylate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Methylheptyl Isostearate, Niacinamide, Nylon-12, Methylpropanediol, Silica, Coco-Caprylate, Allantoin, Bisabolol, Oryza Sativa (Rice) Bran Extract, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Chloride, Polyglyceryl-2 Dipolyhydroxystearate, Caprylyl Glycol, Lecithin, Phenylpropanol, Tetrasodium Glutamate Diacetate, Hydrogenated Lecithin, Sodium Hydroxide, CI 77491, CI77492, CI 77499 (Iron Oxides)
- OTHER INFORMATION
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DAILY SPF PRIMER SPF 50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81545-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 12 g in 100 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL GLYCOL (UNII: 00YIU5438U) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 64-70) (UNII: 96YYQ5TK1K) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) PROPANEDIOL (UNII: 5965N8W85T) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) NYLON-12 (UNII: 446U8J075B) METHYLPROPANEDIOL (UNII: N8F53B3R4R) COCO-CAPRYLATE (UNII: 4828G836N6) NIACINAMIDE (UNII: 25X51I8RD4) ALLANTOIN (UNII: 344S277G0Z) LEVOMENOL (UNII: 24WE03BX2T) RICE BRAN (UNII: R60QEP13IC) HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR) TOCOPHEROL (UNII: R0ZB2556P8) ROSEMARY (UNII: IJ67X351P9) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) SODIUM HYDROXIDE (UNII: 55X04QC32I) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PHENYLPROPANOL (UNII: 0F897O3O4M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81545-102-40 1 in 1 BOX 09/17/2021 1 40 mL in 1 BOTTLE; 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 01/01/2021 Labeler - Lee Indie & Co Inc (117191089)