ABSOLUTELY NATURAL BROAD SPECTRUM SPF 50PLUS SUNSCREEN- zinc oxide lotion

Absolutely Natural Broad Spectrum SPF 50Plus Sunscreen by

Drug Labeling and Warnings

Absolutely Natural Broad Spectrum SPF 50Plus Sunscreen by is a Otc medication manufactured, distributed, or labeled by Absolutely Natural. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 24%

Purpose

Sunscreen

Uses

Helps prevent sunburn.
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help, or contact Poison Control right away.

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

Protect this product from excessive heat and direct sun.

Inactive ingredients

Aloe barbadensis leaf juice, caprylic/capric triglyceride, polyhydroxystearic acid, water, ethylhexyl olivate, squalane, isoamyl laurate, lauryl laurate, sorbitan olivate, copernicia cerifera (carnauba) wax, oryza sativa (rice) bran wax, c13-15 alkane, disteardimonium hectorite, polyglyceryl-3 polyricinoleate, hydrogenated rapeseed oil, capryloyl glycerin/sebacic acid copolymer, silica, propanediol, citrullus lanatus (watermelon) seed oil, butyrospermum parkii (shea) butter, rosa canina fruit oil, cocos nucifera (coconut) oil, helianthus annuus (sunflower) seed oil, camellia sinensis leaf extract, oryza sativa (rice) bran extract, rosmarinus officinalis (rosemary) leaf extract, helianthus annuus (sunflower) extract, tocopherol, sodium phytate, phenoxyethanol, ethylhexylglycerin, sodium chloride, fragrance.

Questions?

Call us! 800-848-7623

SPL UNCLASSIFIED SECTION

EST.1992

Sheer Finish

Mineral Sunscreen

Water Resistant (80 Minutes)

Vegan

REEF SAFE

Manufactured by: Absolutely Natural
640 Atlantis Road
Melbourne, FL 32904

absolutely-natural.com

crueltyfree

MADE IN USA

Packaging

INGREDIENTS AND APPEARANCE

ABSOLUTELY NATURAL BROAD SPECTRUM SPF 50PLUS SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70793-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL OLEATE (UNII: R34927QY59)
SQUALANE (UNII: GW89575KF9)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
LAURYL LAURATE (UNII: GPW77G0937)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CARNAUBA WAX (UNII: R12CBM0EIZ)
RICE BRAN (UNII: R60QEP13IC)
C13-15 ALKANE (UNII: 114P5I43UJ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PROPANEDIOL (UNII: 5965N8W85T)
WATERMELON SEED OIL (UNII: L33J06UQTT)
SHEA BUTTER (UNII: K49155WL9Y)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ROSEMARY (UNII: IJ67X351P9)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
TOCOPHEROL (UNII: R0ZB2556P8)
PHYTATE SODIUM (UNII: 88496G1ERL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70793-034-03	88.72 mL in 1 TUBE; Type 0: Not a Combination Product	05/22/2023
2	NDC: 70793-034-10	10 mL in 1 PACKET; Type 0: Not a Combination Product	05/22/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/22/2023

Labeler - Absolutely Natural (166425202)

Establishment
Name	Address	ID/FEI	Business Operations
Absolutely Natural		166425202	manufacture(70793-034)