SPF 30 SUNSCREEN STICK- avobenzone, homosalate, octisalate, octocrylene stick

SPF 30 Sunscreen Stick by

Drug Labeling and Warnings

SPF 30 Sunscreen Stick by is a Otc medication manufactured, distributed, or labeled by OraLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10%................Sunscreen

Purpose

Sunscreen

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center immediately.

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.

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. Stop use and ask a doctor: if rash or irritation develops and lasts.

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 Sun

Protection Measures.Spending time in the sun increases your risk of skin cancer and

early skin aging To decrease the risk, regularly use a sunscreen with a broad spectrum

SPF 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-sleeve shirts, pants, hats and sunglasses.

Inactive Ingredients

Paraffin wax, octyl palmitate, ozokerite, euphorbia cerifera (candelilla) wax, beeswax, butyloctyl salicylate, fragrance, polyethylene, polycrylene, cetyl alcohol, tocopheryl acetate, ascorbyl palmitate

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

SPF 30 SUNSCREEN STICK 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63645-329
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)	240 mg  in 1 g
ETHYLHEXYL PALMITATE (UNII: 2865993309)	200 mg  in 1 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63645-329-01	13 g in 1 CONTAINER; Type 0: Not a Combination Product	12/08/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	352	12/08/2025

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	manufacture(63645-329) , label(63645-329) , analysis(63645-329)