Label: NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40ML WITH WILD ROSELLA SPF 50- titanium oxide, zinc oxide liquid
- NDC Code(s): 62282-985-01, 62282-985-02, 62282-985-03
- Packager: Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 3, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- USES
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WARNINGS
Warnings: For external use only. Do not use
on damaged or broken skin Avoid prolonged
sun exposure. If it gets in your eyes, wash well
with water. Keep out of reach of children.
Stop use and ask a doctor if rashes occur.
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
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INACTIVE INGREDIENTS
Inactive Ingredients: Aluminum Hydroxide,
Aqua, Butyloctyl Salicylate, C12-15 Alkyl
Benzoate, Coco-Caprylate/Caprate, Dimethicone,
Ethylhexyl Methoxycrylene, Ethylhexylglycerin,
Hydroxyacetophenone, Iron Oxides, Isododecane,
Isostearic Acid, Lauryl PEG-8 Dimethicone,
Magnesium Sulfate, Mica, Phenoxyethanol,
Polyglyceryl-2 Tetraisostearate, Polyglyceryl-2
Tetraisostearate, Polyglyceryl-3 Polyricinoleate,
Propanediol, Sodium Hyaluronate, Stearic Acid,
Hibiscus Sabdariffa Flower Extract - OTHER INFORMATION
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USER SAFETY WARNINGS
Directions: Shake well before use.
Apply liberally and reapply every 80 minutes,
especially after swimming or towel drying.
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 lime in the sun,
especially from 10 am-2 pm Wear longsleeved
shirts, pants, hats, and sunglasses For
Children under 6 months of age ask a doctor - Label
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INGREDIENTS AND APPEARANCE
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40ML WITH WILD ROSELLA SPF 50
titanium oxide, zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62282-985 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.3 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 14.9 g in 100 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) FERRIC OXIDE RED (UNII: 1K09F3G675) ISOSTEARIC ACID (UNII: X33R8U0062) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERYL-2 TETRAISOSTEARATE (UNII: KN8R167SEQ) PROPANEDIOL (UNII: 5965N8W85T) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8) MICA (UNII: V8A1AW0880) MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) ISODODECANE (UNII: A8289P68Y2) HYALURONATE SODIUM (UNII: YSE9PPT4TH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62282-985-01 40 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 06/30/2023 2 NDC:62282-985-02 50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 06/30/2023 3 NDC:62282-985-03 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 06/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/30/2023 Labeler - Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho (929572014)