Label: NAKED SUNDAYS BROAD SPECTRUM SUNSCREEN SPF 50- zinc oxide cream
- NDC Code(s): 81104-003-01
- 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
Inactive Ingredients: Ricinus Communis
(Castor) Seed Oil, C12-15 Alkyl Benzoate,
Coco-Caprylate/Caprate, Euphorbia Cerifera
(Candelilla) Wax, Copernicia Cerifera (Carnauba)
Wax, Ceresin, Theobroma Cacao (Cocoa) Seed
Butter, Polyglyceryl-3 Polyricinoleate, Isostearic
Acid, Tocopheryl Acetate, Persea Gratissima
(Avocado) Oil, Iron Oxides (CI 77492, CI 77491) - OTHER INFORMATION
- USER SAFETY WARNINGS
-
directions
Directions: Apply generously 20 minutes before
sun exposure. Reapply after 90 minutes, especially
after swimming, exercising or towel drying. 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 value of 15 or
higher and other sun protection measures including:
Limit time in the sun, especially from 10AM - 2PM
Wear long-sleeved shirts, pants, hats, and
sunglasses Children under 6 months of age: Ask a
doctor. - Label
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INGREDIENTS AND APPEARANCE
NAKED SUNDAYS BROAD SPECTRUM SUNSCREEN SPF 50
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81104-003 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 g Inactive Ingredients Ingredient Name Strength THEOBROMA CACAO WHOLE (UNII: EB048G1S9J) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C) ISOSTEARIC ACID (UNII: X33R8U0062) AVOCADO OIL (UNII: 6VNO72PFC1) FERRIC OXIDE RED (UNII: 1K09F3G675) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) CERESIN (UNII: Q1LS2UJO3A) CARNAUBA WAX (UNII: R12CBM0EIZ) CANDELILLA WAX (UNII: WL0328HX19) RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81104-003-01 19 g in 1 TUBE; 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 - NAKED SUNDAYS PTY LTD (746918845)
