PROTECT AND HYDRATE RADIANCE SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream

Protect and Hydrate Radiance Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Protect and Hydrate Radiance Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Baxter Laboratories Pty. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10%

Octisalate5%

Octocrylene 8%

PURPOSE

Uses

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

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.

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure.

apply to all skin exposed to the sun

reapply:

• 80 minutes of swimming or sweating
• immediately after towel drying
• 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 10 a.m.- 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor.

INACTIVE INGREDIENT

Water, Beeswax, Cyclomethicone, Cetearyl Alcohol, Isopropyl Palmitate, Ceteareth-20, Fragrance, Benzyl Alcohol, Hydroxyacetophenone, Carbomer, Phenoxyethanol, Triethanolamine, Sodium Stearoyl Glutamate, Mica, Iron Oxides, Tocopheryl Acetate, Titanium Dioxide, Maltodextrin, Aloe Barbadensis Leaf Juice, Citric

PRINCIPAL DISPLAY PANEL

Protect & Hydrate Radiance

Shimmer Finish

Sunscreen Broad Spectrum SPF 50+

Water Resistant (80 Minutes)

5.0 fl. oz. (148 mL)

INGREDIENTS AND APPEARANCE

PROTECT AND HYDRATE RADIANCE SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70157-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
CITRIC ACID (UNII: 2968PHW8QP)
CYCLOMETHICONE (UNII: NMQ347994Z)
BEESWAX (UNII: 2ZA36H0S2V)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETEARETH-20 (UNII: YRC528SWUY)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
MICA (UNII: V8A1AW0880)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROUS OXIDE (UNII: G7036X8B5H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70157-030-02	1 in 1 CARTON	09/30/2024
1	NDC: 70157-030-01	148 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/30/2024

Labeler - Baxter Laboratories Pty. Ltd. (740537709)