Label: NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS SHEER TINT 15ML SPF 50- zinc oxide liquid
- NDC Code(s): 81104-258-01
- Packager: NAKED SUNDAYS PTY LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 29, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- USES
-
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
Aluminium Hydroxide,
Butyloctyl Salicylate, C12-15 Alkyl Benzoate,
Coco-Caprylate/Caprate, Dimethicone, Dunaliella
Salina Extract, Ethylhexyl Methoxycrylene,
Ethylhexylglycerin, Hibiscus Sabdariffa Flower
Extract, Hydroxyacetophenone, Iron Oxides/(CI
77491, CI 77492, CI 77499), Isododecane, Isostearic
Acid, Lauryl PEG-8 Dimethicone, Magnesium
Sulfate, Phenoxyethanol, Polyglyceryl-3
Polyricinoleate, Propanediol, Purified Water,
Simmondsia Chinensis (Jojoba) Seed Oil, Sodium
Hyaluronate, Stearic Acid, Titanium Dioxide/CI 77891 - 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 - PURPOSE
- Label
-
INGREDIENTS AND APPEARANCE
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS SHEER TINT 15ML SPF 50
zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81104-258 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) FERRIC OXIDE RED (UNII: 1K09F3G675) ISOSTEARIC ACID (UNII: X33R8U0062) WATER (UNII: 059QF0KO0R) PROPANEDIOL (UNII: 5965N8W85T) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) PHENOXYETHANOL (UNII: HIE492ZZ3T) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8) JOJOBA OIL (UNII: 724GKU717M) MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) STEARIC ACID (UNII: 4ELV7Z65AP) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) ISODODECANE (UNII: A8289P68Y2) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DUNALIELLA SALINA (UNII: F4O1DKI9A6) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81104-258-01 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 12/20/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/30/2023 Labeler - NAKED SUNDAYS PTY LTD (746918845)
