Label: DAYTIME DEFENSE SPF 30- zinc oxide cream
- NDC Code(s): 66915-611-01, 66915-611-02, 66915-611-03
- Packager: CoValence, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT
Active Ingredients: Zinc Oxide 13.5%
- KEEP OUT OF REACH OF CHILDREN
Warnings: Keep our of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.Close
- INDICATIONS & USAGE
- Helps prevent sunburn
- For skin highly sensitive to sunburn
- 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 ask a doctor if rash occurs
- Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
- DOSAGE & ADMINISTRATION
- Apply liberally 15 minutes before sun exposure.
- Use water resistant sunscreen if swimming or sweating.
- Reapply 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 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.
- INACTIVE INGREDIENT
Aqua (Water). Caprylic/Capric Triglyceride, Glycerin, Ethyl Macadamiate, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glyceryl Stearate, Isodecyl Neopentanoate, Polyglyceryl-10 Pentastearate, Hydrolyzed Starch Phosphate, Cirtric Acid, Cetearyl Alcohol, Sodium Stearoyl Lactylate, Behenyl Alcohol, Phellodendrom Amurense (Cork Tree) Bark Extract, Glyceryl Isostearate, Hydroxypropyl Methylcellulose, Sodium Stearoyl Lactylate, Alcohol Denatured, Santalum Album (Sandalwood) Extract, Hordeum Distichon (Barley) Extract, Artemisia Vulgaris (Mugwort) Extract, Algae Extract, Malic Acid, Tocopherol, Hamamelis Virginiana (Witch Hazel) Water, Lonicera Caprifolium (Honeysuckle) Flower Extract, Sodium Chloride, Sodium HydroxideClose
- PRINCIPAL DISPLAY PANEL
Principal Display Panel:Close
- INGREDIENTS AND APPEARANCE
DAYTIME DEFENSE SPF 30
zinc oxide cream
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66915-611 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC OXIDE) ZINC OXIDE .135 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER MEDIUM-CHAIN TRIGLYCERIDES ETHYL MACADAMIATE ISODECYL NEOPENTANOATE GLYCERIN GLYCERYL MONOSTEARATE BARLEY LAVENDER OIL SANDALWOOD PHELLODENDRON AMURENSE BARK ARTEMISIA VULGARIS ROOT .ALPHA.-TOCOPHEROL, DL- MALIC ACID, L- LONICERA CAPRIFOLIUM FLOWER LONICERA JAPONICA FLOWER GLYCERYL ISOSTEARATE SODIUM STEAROYL LACTYLATE DOCOSANOL CETOSTEARYL ALCOHOL POLYHYDROXYSTEARIC ACID (2300 MW) SODIUM CHLORIDE HAMAMELIS VIRGINIANA TOP WATER ALCOHOL CITRIC ACID MONOHYDRATE FYTIC ACID Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66915-611-01 200000 g in 1 DRUM 2 NDC:66915-611-02 30 g in 1 BOTTLE, PLASTIC 3 NDC:66915-611-03 120 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/26/2012 Labeler - CoValence, Inc. (070653204) Registrant - CoValence, Inc. (070653204) Establishment Name Address ID/FEI Business Operations CoValence, Inc. 070653204 manufacture(66915-611)