Spf 50+ Sunscreen Stick

Spf 50+ Sunscreen Stick
SPL v3
SPL
SPL Set ID 247aae3d-1845-4dd8-b774-b9e8214809a2
Route
TOPICAL
Published
Effective Date 2024-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (79 mg) Zinc Oxide (67 mg)
Inactive Ingredients
Alkyl (c12-15) Benzoate Yellow Wax Carnauba Wax Medium-chain Triglycerides Neopentyl Glycol Diethylhexanoate Tribehenin Candelilla Wax Ppg-3 Benzyl Ether Myristate Myristyl Myristate Helianthus Annuus Seed Wax Stearyl/octyldodecyl Citrate Crosspolymer Jojoba Oil Polyglyceryl-10 Pentaoleate Caprylyl Glycol Ethylhexylglycerin Jojoba Oil, Randomized Raspberry Seed Oil Cranberry Seed Oil Sunflower Oil Tomato Seed Oil Nigella Sativa Seed Oil Polyhydroxystearic Acid (2300 Mw) Silicon Dioxide Aluminum Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-06-21 Until 2025-12-31

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 and evenly 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • this product is meant for targeted protection and small areas of exposed skin
  • for full protection use in conjunction with another sunscreen lotion or spray
  • 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
  • keep outer card for full drug facts
Active Ingredients

Titanium Dioxide 7.9%, Zinc Oxide 6.7%

Inactive Ingredients

C12-15 alkyl benzoate, caprylic/capric triglyceride, beeswax

Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic
, copernicia cerifera (carnauba) wax
, neopentyl glycol diethylhexanoate, tribehenin, euphorbia cerifera (candelilla) wax, PPG-3 benzyl ether myristate, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, helianthus annuus (sunflower) seed wax, myristyl myristate, stearyl/octadodecyl citrate crosspolymer, simmondsia chinensis (jojoba) seed oil
, polyglyceryl-10 pentaoleate, jojoba esters, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil
, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil
, rubus idaeus (raspberry) seed oil, polyhydroxystearic acid, caprylyl glycol, ethylhexylglycerin, silica, alumina

Principal Display Panel 45.5 G Applicator Label

50+

SPF

babyganics

kids

SPF 50+ sunscreen stick

all mineral active ingredients

broad spectrum SPF 50+

UVA + UVB protection

non-allergenic • water &

sweat resistant (80 minutes)

tear free • pediatrician &

dermatologist tested

formulated with: Titanium

Dioxide, Zinc Oxide*

formulated without: PABA

phthalates • parabens

fragrances • nano-particles

Discover which of our

ingredients are Certified

Organic on back panel.

Net. Wt. 1.6 OZ (45.5 g)

040-17936-B01

Principal Display Panel 13 G Applicator Blister Pack

babyganics®

SPF 50 mineral sunscreen

broad spectrum SPF 50

pediatrician

&

dermatologist

tested

water

resistant

(80 minutes)

Discover which of

our ingredients are

Certified Organic

on back panel.

NET WT 0.47 OZ (13 g)


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 and evenly 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • this product is meant for targeted protection and small areas of exposed skin
  • for full protection use in conjunction with another sunscreen lotion or spray
  • 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
  • keep outer card for full drug facts
Active Ingredients (Active ingredients)

Titanium Dioxide 7.9%, Zinc Oxide 6.7%

Inactive Ingredients (Inactive ingredients)

C12-15 alkyl benzoate, caprylic/capric triglyceride, beeswax

Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic
, copernicia cerifera (carnauba) wax
, neopentyl glycol diethylhexanoate, tribehenin, euphorbia cerifera (candelilla) wax, PPG-3 benzyl ether myristate, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, helianthus annuus (sunflower) seed wax, myristyl myristate, stearyl/octadodecyl citrate crosspolymer, simmondsia chinensis (jojoba) seed oil
, polyglyceryl-10 pentaoleate, jojoba esters, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil
, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil
, rubus idaeus (raspberry) seed oil, polyhydroxystearic acid, caprylyl glycol, ethylhexylglycerin, silica, alumina

Principal Display Panel 45.5 G Applicator Label (PRINCIPAL DISPLAY PANEL - 45.5 g Applicator Label)

50+

SPF

babyganics

kids

SPF 50+ sunscreen stick

all mineral active ingredients

broad spectrum SPF 50+

UVA + UVB protection

non-allergenic • water &

sweat resistant (80 minutes)

tear free • pediatrician &

dermatologist tested

formulated with: Titanium

Dioxide, Zinc Oxide*

formulated without: PABA

phthalates • parabens

fragrances • nano-particles

Discover which of our

ingredients are Certified

Organic on back panel.

Net. Wt. 1.6 OZ (45.5 g)

040-17936-B01

Principal Display Panel 13 G Applicator Blister Pack (PRINCIPAL DISPLAY PANEL - 13 g Applicator Blister Pack)

babyganics®

SPF 50 mineral sunscreen

broad spectrum SPF 50

pediatrician

&

dermatologist

tested

water

resistant

(80 minutes)

Discover which of

our ingredients are

Certified Organic

on back panel.

NET WT 0.47 OZ (13 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)