Outdoor Essentials

Outdoor Essentials
SPL v2
SPL
SPL Set ID 93ef5b1b-e4f4-4c86-a395-c19861866c3e
Route
TOPICAL
Published
Effective Date 2021-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (112 mg) Octisalate (50 mg) Octocrylene (60 mg)
Inactive Ingredients
Water Medium-chain Triglycerides Glycerin Butyloctyl Salicylate Stearyl/octyldodecyl Citrate Crosspolymer Glyceryl Monostearate Polyglyceryl-6 Polyricinoleate Polysorbate 80 Phenylethyl Alcohol Glyceryl Monocaprylate Laponite Xanthan Gum Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Citric Acid Monohydrate Squalane Tomato Seed Oil Sunflower Oil Lecithin, Soybean Polysorbate 60 Aloe Vera Leaf Cranberry Seed Oil Raspberry Seed Oil Nigella Sativa Seed Oil Sorbitan Isostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-01-01

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
    • do not spray directly into face. Spray on hands then apply to face.
  • 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

Zinc Oxide 11.20%, Octocrylene 6.0%, Octisalate 5.0%

Inactive Ingredients

water, caprylic/capric triglyceride, glycerin, butyloctyl salicylate, stearyl/octyldodecyl citrate crosspolymer, aloe barbadensis leaf juice, glyceryl stearate, polyglyceryl-6 polyricinoleate, helianthus annuus (sunflower) seed oil, solanum lycopersicum (tomato) seed oil, lecithin, polysorbate 60, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil organic, rubus idaeus (raspberry) seed oil, squalane, xanthan gum, polysorbate 80, phenethyl alcohol, glyceryl caprylate, lithium magnesium sodium silicate, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, sorbitan isostearate, citric acid

Principal Display Panel Kit Carton

outdoor essentials

babyganics

SPF 50+

sunscreen spray

broad spectrum SPF 50+

UVA + UVB protection ∙ non-allergenic

water resistant (80 minutes)

natural

insect repellent

plant and essential oils help keep

mosquitoes away

Discover which of our ingredients are Certified Organic on back panel.

6 FL OZ (177 mL)

6 FL OZ (177 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
    • do not spray directly into face. Spray on hands then apply to face.
  • 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)

Zinc Oxide 11.20%, Octocrylene 6.0%, Octisalate 5.0%

Inactive Ingredients (Inactive ingredients)

water, caprylic/capric triglyceride, glycerin, butyloctyl salicylate, stearyl/octyldodecyl citrate crosspolymer, aloe barbadensis leaf juice, glyceryl stearate, polyglyceryl-6 polyricinoleate, helianthus annuus (sunflower) seed oil, solanum lycopersicum (tomato) seed oil, lecithin, polysorbate 60, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil organic, rubus idaeus (raspberry) seed oil, squalane, xanthan gum, polysorbate 80, phenethyl alcohol, glyceryl caprylate, lithium magnesium sodium silicate, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, sorbitan isostearate, citric acid

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

outdoor essentials

babyganics

SPF 50+

sunscreen spray

broad spectrum SPF 50+

UVA + UVB protection ∙ non-allergenic

water resistant (80 minutes)

natural

insect repellent

plant and essential oils help keep

mosquitoes away

Discover which of our ingredients are Certified Organic on back panel.

6 FL OZ (177 mL)

6 FL OZ (177 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)