Label: TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF 25- zinc oxide lotion
- NDC Code(s): 72812-152-01
- Packager: Earth Mama Angel Baby, LLC
- 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 August 30, 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 generously and evenly to all skin exposed to sun 15 minutes before sun exposure • 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 • Reapply • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours
- Other Information
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Inactive Ingredients
Caprylic/Caprylic Triglyceride*, Cocos Nucifera (Coconut) Oil*, Olea Europaea (Olive) Fruit Oil*, Beeswax*, Helianthus Annuus (Sunflower) Seed Oil*, Simmondsia Chinensis (Jojoba) Oil*, Butyrospermum Parkii (Shea) Butter*, Rubus Idaeus (Raspberry) Seed Oil*, Argania Spinosa Kernel Oil*, Tocopherol, Rosa Canina (Rosehip) Seed Oil*, Calendula Officinalis Flower Extract*, Iron Oxides, Mica
*Organic
- Questions or comments?
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SPL UNCLASSIFIED SECTION
Dermatologist Tested & Clinically Tested for Irritation
Water Resistant (40 Minutes)
UVA/UVB Protection
Reef Friendly
Contains Organic Argan Oil & Organic Raspberry Seed Oil
Non-Nano, NO Parabens, NO Artificial Fragrance
NSF
contains organic ingredientsTinted Moisturizing
Mineral Sun Protection
Grounded in Nature, Powered by Love.™
Distributed by
Earth Mama Angel Baby® LLC
9866 SE Empire Ct.
Clackamas, OR 97015 USA
Certified to NSF/ANSI
305 by Oregon Tilth
- Packaging
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INGREDIENTS AND APPEARANCE
TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF 25
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72812-152 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCONUT OIL (UNII: Q9L0O73W7L) OLIVE OIL (UNII: 6UYK2W1W1E) YELLOW WAX (UNII: 2ZA36H0S2V) SUNFLOWER OIL (UNII: 3W1JG795YI) JOJOBA OIL (UNII: 724GKU717M) SHEA BUTTER (UNII: K49155WL9Y) RASPBERRY SEED OIL (UNII: 9S8867952A) ARGAN OIL (UNII: 4V59G5UW9X) TOCOPHEROL (UNII: R0ZB2556P8) ROSA CANINA SEED OIL (UNII: MHT97MG5P8) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72812-152-01 84 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/01/2020 Labeler - Earth Mama Angel Baby, LLC (603560686)
