DAILY SPF PRIMER SPF 50- zinc oxide lotion

DAILY SPF PRIMER by

Drug Labeling and Warnings

DAILY SPF PRIMER by is a Otc medication manufactured, distributed, or labeled by Lee Indie & Co Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ZINC OXIDE 12%

PURPOSE

SUNSCREEN

USES

• HELPS PREVENT SUNBURN
• 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

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 A PHYSICIAN IF RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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

Protect this product from excessive heat and direct sun. Store below 90°F (32°C).

QUESTIONS OR COMMENTS?

1 (866) 488-1638 MON-FRI (9 A.M. - 5 P.M. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAILY SPF PRIMER  SPF 50
zinc oxide lotion

Product 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)