Outdoor Adventure Set

Outdoor Adventure Set
SPL v1
SPL
SPL Set ID 8f0f2707-7fd6-491d-a928-7d420b17da80
Route
TOPICAL
Published
Effective Date 2020-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (30 mg) Octisalate (50 mg) Zinc Oxide (60 mg)
Inactive Ingredients
Water Butyloctyl Salicylate Neopentyl Glycol Diethylhexanoate Medium-chain Triglycerides Stearyl/octyldodecyl Citrate Crosspolymer Polyglyceryl-2 Stearate Cetyl Alcohol Jojoba Oil Glyceryl Monostearate Glycerin Coconut Oil Tomato Seed Oil Sunflower Oil Ethylhexylglycerin Cranberry Seed Oil Nigella Sativa Seed Oil Raspberry Seed Oil Phenoxyethanol Xanthan Gum Shea Butter Jojoba Oil, Randomized Stearyl Alcohol Arachidyl Alcohol Arachidyl Glucoside Docosanol Polyhydroxystearic Acid Stearate Silicon Dioxide Aluminum Oxide Trisodium Ethylenediamine Disuccinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-01-01
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin

Warnings

For external use only

Directions
  • apply liberally 15 minutes before 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

Active Ingredients

Octisalate 5.0%, Titanium Dioxide 3.0%, Zinc Oxide 6.0%

Inactive Ingredients

water, butyloctyl salicylate, neopentyl glycol diethylhexanoate, caprylic/capric triglyceride, stearyl/octyldodecyl citrate crosspolymer, polyglyceryl-2 stearate, simmondsia chinensis (jojoba) seed oil

Certified Organic Ingredient

Unless otherwise specified, product not labeled as organic
, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, glyceryl stearate, cetyl alcohol, cocos nucifera (coconut) oil
, glycerin
, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil
, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil
, rubus idaeus (red raspberry) seed oil, butyrospermum parkii (shea) butter
, jojoba esters, stearyl alcohol, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, polyhydroxystearic acid, xanthan gum, silica, alumina, ethylhexylglycerin, trisodium ethylenediamine disuccinate, phenoxyethanol

Principal Display Panel Kit Package

babyganics

outdoor

adventure set

mosquito bites?

sun burns? we've

got you covered

Discover which of our

ingredients are Certified

Organic on back panel.

natural insect

repellent

5 FL OZ (142 g)

SPF 50+

sunscreen lotion

2 FL OZ (59 mL)

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply liberally 15 minutes before 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 (Other information)

protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Octisalate 5.0%, Titanium Dioxide 3.0%, Zinc Oxide 6.0%

Inactive Ingredients (Inactive ingredients)

water, butyloctyl salicylate, neopentyl glycol diethylhexanoate, caprylic/capric triglyceride, stearyl/octyldodecyl citrate crosspolymer, polyglyceryl-2 stearate, simmondsia chinensis (jojoba) seed oil

Certified Organic Ingredient

Unless otherwise specified, product not labeled as organic
, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, glyceryl stearate, cetyl alcohol, cocos nucifera (coconut) oil
, glycerin
, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil
, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil
, rubus idaeus (red raspberry) seed oil, butyrospermum parkii (shea) butter
, jojoba esters, stearyl alcohol, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, polyhydroxystearic acid, xanthan gum, silica, alumina, ethylhexylglycerin, trisodium ethylenediamine disuccinate, phenoxyethanol

Principal Display Panel Kit Package (PRINCIPAL DISPLAY PANEL - Kit Package)

babyganics

outdoor

adventure set

mosquito bites?

sun burns? we've

got you covered

Discover which of our

ingredients are Certified

Organic on back panel.

natural insect

repellent

5 FL OZ (142 g)

SPF 50+

sunscreen lotion

2 FL OZ (59 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:05.177908 · Updated: 2026-03-14T22:58:55.175271