Label: NAKED SUNDAYS COLLAGEN GLOW 100% MINERAL SUNSCREEN SPF 50- zinc oxide liquid
- NDC Code(s): 62282-002-01
- Packager: Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho -
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 9, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- USES
-
WARNINGS
Warnings: For external use only.
Skin Cancer/Skin Aging Alert: Spending time in the
sun increases your risk of skin cancer and early skin
aging. This product has been shown only to help
prevent sunburn, not skin cancer or early skin aging
Do not use on damaged or broken skin. 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.Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
DIRECTIONS
- SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE.
- Reapply after 80 minutes of swimming or sweating.
- Reapply immediately after towel drying.
- Reapply at least every 2 hours.
- Children under 3 years 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 10.00AM - 2.00PM
- Wear long-sleeved shirts, pants, hats, and sunglasses
-
INACTIVE INGREDIENTS
Inactive Ingredients:
Aqua, Coco-Caprylate/Caprate, Octyldodecanol,
Caprylic/Capric Triglyceride, PEG-30
Dipolyhydroxystearate, Glycerin, Cetearyl alcohol,
Polyglyceryl-3 Polyricinoleate, Citrullus Lanatus
(Watermelon) Seed Oil, Disodium EDTA, Sodium
chloride, Xanthan Gum, Gluconolactone, Isostearic
acid, Cetearyl glucoside, Sodium benzoate,
Hydrolyzed Soy Protein, Rice amino acids, Calcium
Gluconate, Proline, Hydrolyzed Adansonia Digitata
Seed Extract, Iron Oxides. - OTHER INFORMATION
-
USER SAFETY WARNINGS
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 10AM to 2PM
Wear long-sleeved shirts, pants, hats, and sunglasses - directions
- Label
-
INGREDIENTS AND APPEARANCE
NAKED SUNDAYS COLLAGEN GLOW 100% MINERAL SUNSCREEN SPF 50
zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62282-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 22.75 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) GLUCONOLACTONE (UNII: WQ29KQ9POT) PROLINE (UNII: 9DLQ4CIU6V) OCTYLDODECANOL (UNII: 461N1O614Y) PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) WATERMELON SEED OIL (UNII: L33J06UQTT) SODIUM CHLORIDE (UNII: 451W47IQ8X) ISOSTEARIC ACID (UNII: X33R8U0062) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) SODIUM BENZOATE (UNII: OJ245FE5EU) ADANSONIA DIGITATA SEED (UNII: 2936P60TPX) FERRIC OXIDE RED (UNII: 1K09F3G675) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) AMINO ACIDS, RICE (UNII: 5ET1T25H82) CALCIUM GLUCONATE (UNII: SQE6VB453K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62282-002-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/06/2023 Labeler - Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho - (929572014) Establishment Name Address ID/FEI Business Operations Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho - 929572014 manufacture(62282-002)
