85950-004 Bellas Friends Roll-on Sunscreen

85950-004 Bellas Friends Roll-on Sunscreen
SPL v1
SPL
SPL Set ID 478d46ce-14e8-2231-e063-6394a90a3e27
Route
TOPICAL
Published
Effective Date 2026-01-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (7 g) Titanium Dioxide (4 g)
Inactive Ingredients
Purslane Water Butylene Glycol Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Chrysanthellum Indicum Flower Oil Caprylic/capric/succinic Triglyceride Disteardimonium Hectorite Tocopherol Aloe Barbadensis Leaf Triethoxycaprylylsilane Osmanthus Fragrans Flower Hydrogenated Polyisobutene 8 Dimethicone Butylene Glycol Dicaprylate/dicaprate Silicon Dioxide Glycerin Trimethylsiloxysilicate (m/q 0.6-0.8) Sophora Flavescens Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-04

Description

Active ingredients Purpose Titanium dioxide 4%,Zinc oxide 7% ................Sunscreen


Medication Information

Warnings and Precautions

Warnings For external use only

Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with waterto remove.

Stop use and ask a doctor if rash occurs

Indications and Usage

children under6 months of age:ask a doctor .Sun Protection Mleasures.Spending time in the sun increases your risk of skin cancerand early skin aging. To decrease this risk, reqularly usea sunscreen with a Broad Spectrum SPF value of 15 orhigher and other sun protection measures including:limittime in the sun, especially from 10 a.m.-2 p.m. .wear long-sleeved shirts, pants, hats, and sunglasses

Dosage and Administration

shake well before use .apply liberally and spread by hand 15 minutes before sun exposure .reapply:.after 80 minutes of swimming or sweating.immediatelyafter towel drying.at least every 2 hours

Description

Active ingredients Purpose Titanium dioxide 4%,Zinc oxide 7% ................Sunscreen

Section 50565-1

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center immediately.

Section 51727-6

Inactive ingredientswater,caprylic/capric triglyceride,dimethicone,tocopherol,glycerin, hydrogenated polyisobutene, butylene glycol dicaprylate/dicaprate,silica / silicon dioxide,vinyldimethicone/methicone silsesquioxane crosspolymer,triethoxycaprylylsilane,Osmanthus fragrans flower extract,trimethylsiloxysilicate, disteardimonium hectorite,butyleneglycol, Portulaca oleracea extract, Chrysanthellum indicum,Aloe barbadensis extract, Sophora angustifolia root extract.

Section 51945-4

Section 55105-1

USe.helps prevent sunburn .if used as directed with othersun protection measures(see Directions decreases the risk of skin cancer and early skin aging caused by the sun

Section 55106-9

Active ingredients

Purpose

Titanium dioxide 4%,Zinc oxide 7% ................Sunscreen


Structured Label Content

Indications and Usage (34067-9)

children under6 months of age:ask a doctor .Sun Protection Mleasures.Spending time in the sun increases your risk of skin cancerand early skin aging. To decrease this risk, reqularly usea sunscreen with a Broad Spectrum SPF value of 15 orhigher and other sun protection measures including:limittime in the sun, especially from 10 a.m.-2 p.m. .wear long-sleeved shirts, pants, hats, and sunglasses

Dosage and Administration (34068-7)

shake well before use .apply liberally and spread by hand 15 minutes before sun exposure .reapply:.after 80 minutes of swimming or sweating.immediatelyafter towel drying.at least every 2 hours

Warnings and Precautions (34071-1)

Warnings For external use only

Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with waterto remove.

Stop use and ask a doctor if rash occurs

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Inactive ingredientswater,caprylic/capric triglyceride,dimethicone,tocopherol,glycerin, hydrogenated polyisobutene, butylene glycol dicaprylate/dicaprate,silica / silicon dioxide,vinyldimethicone/methicone silsesquioxane crosspolymer,triethoxycaprylylsilane,Osmanthus fragrans flower extract,trimethylsiloxysilicate, disteardimonium hectorite,butyleneglycol, Portulaca oleracea extract, Chrysanthellum indicum,Aloe barbadensis extract, Sophora angustifolia root extract.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

USe.helps prevent sunburn .if used as directed with othersun protection measures(see Directions decreases the risk of skin cancer and early skin aging caused by the sun

Section 55106-9 (55106-9)

Active ingredients

Purpose

Titanium dioxide 4%,Zinc oxide 7% ................Sunscreen


Advanced Ingredient Data


Raw Label Data

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