Label: ZOEY NATURALS BROAD SPECTRUM SPF 50 FRAGRANCE FREE SUNSCREEN- zinc oxide stick
- NDC Code(s): 70793-033-68
- Packager: Absolutely Natural
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 19, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
• Apply liberally and evenly 15 minutes prior to sun exposure.
• Reapply after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours.
• Children under 6 months 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 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses. - Other information
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Inactive ingredients
Cocos nucifera (coconut) oil, euphorbia cerifera (candelilla) wax, helianthus annuus (sunflower) seed wax, olea europaea (olive) oil unsaponifiables, rhus verniciflua peel wax, shorea robusta resin, lauryl laurate, polyhydroxystearic acid, theobroma cacao (cocoa) seed butter, caprylic/capric triglyceride, copernicia cerifera (carnauba) wax, calcium silicate, argania spinosa kernel oil, tocopheryl acetate, bisabolol, butyrospermum parkii (shea) butter, glyceryl caprylate, glyceryl undecylenate, citrus aurantium dulcis peel wax, oryza sativa (rice) bran extract, rosmarinus officinalis (rosemary) leaf extract, helianthus annuus (sunflower) extract, tocopherol.
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SPL UNCLASSIFIED SECTION
WATER RESISTANT (80 MINUTES)
MINERAL SUNSCREEN, VEGAN
MINERAL FACE & BODY STICK helps prevent sunburn and is infused with nutrients to keep your little one's skin nourished while in the sun.
√ Reef Safe
√ Sensitive Skin
√ Hypoallergenic
√ No Harsh Chemicals
ZOEY naturals® is formulated for babies and loved by mamas all around the world. Our effective and gentle formulas are free of harsh chemicals and safe on the environment.
Distributed by: Zoey Naturals 640 Atlantis Road, Melbourne, FL 32904
www. Zoey-Naturals.com
made for babies. loved by mamas.®
Crueltyfree
MADE IN USA
- Packaging
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INGREDIENTS AND APPEARANCE
ZOEY NATURALS BROAD SPECTRUM SPF 50 FRAGRANCE FREE SUNSCREEN
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70793-033 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 19 g in 100 g Inactive Ingredients Ingredient Name Strength COCONUT OIL (UNII: Q9L0O73W7L) CANDELILLA WAX (UNII: WL0328HX19) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT) TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH) SHOREA ROBUSTA RESIN (UNII: XUK1106UBO) LAURYL LAURATE (UNII: GPW77G0937) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) COCOA BUTTER (UNII: 512OYT1CRR) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CARNAUBA WAX (UNII: R12CBM0EIZ) CALCIUM SILICATE (UNII: S4255P4G5M) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LEVOMENOL (UNII: 24WE03BX2T) SHEA BUTTER (UNII: K49155WL9Y) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) ORANGE PEEL WAX (UNII: 0U715N387C) RICE BRAN (UNII: R60QEP13IC) ROSEMARY (UNII: IJ67X351P9) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70793-033-68 1 in 1 CARTON 05/19/2023 1 19.5 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/19/2023 Labeler - Absolutely Natural (166425202) Establishment Name Address ID/FEI Business Operations Absolutely Natural 166425202 manufacture(70793-033)