61010-6103, Sunscreen

61010-6103, Sunscreen
SPL v6
SPL
SPL Set ID 754186c8-3c88-40a0-a4e3-35e3ea9d1b4c
Route
TOPICAL
Published
Effective Date 2013-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (6 mg) Octinoxate (7.5 mg) Octisalate (5 mg) Oxybenzone
Inactive Ingredients
Cetyl Alcohol Povidone K30 Propylene Glycol Propylparaben Methylparaben Diazolidinyl Urea Polyoxyl 40 Stearate Polysorbate 60 Petrolatum Water Sorbitan Monostearate Edetate Sodium Titanium Dioxide Xanthan Gum Polyethylene Glycol 400 Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-03-13
Description

Drug Facts

Purpose

Sunscreens

Medication Information

Purpose

Sunscreens

Description

Drug Facts

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • for skin highly sensitive to sunburn
Section 42229-5

Drug Facts

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50570-1

Do not use on damaged or broken skin.

Section 51945-4

PRINCIPAL DISPLAY PANEL – 25 count box

NDC 61010-6103-1

Safetec

Sunscreen

Lotion

SPF 30

PABA Free

25 Packets

3.5 g (1/8 oz.)

Reorder no. 53700

Warnings

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.

Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every two hours
  • children under 6 months: ask a doctor
  • protect from excessive heat and direct sun
Active Ingredient

Homosalate (6.0%)

Octinoxate (7.5%)

Octisalate (5.0%)

Oxybenzone (5.0%)

Inactive Ingredients

cetyl alcohol, ganex P-904, germaben II, petrolatum, polyoxyl 40 stearate, polysorbate 60, purified water, sorbitan monostearate, tetrasodium EDTA, titanium dioxide, xanthan gum, zenicone XX

When Using This Product
  • keep out of eyes
  • rinse with water to remove
Keep Out of Reach of Children.

If swallowed, get medical help or contact a poison control center right away

Structured Label Content

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • for skin highly sensitive to sunburn
Section 42229-5 (42229-5)

Drug Facts

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL – 25 count box

NDC 61010-6103-1

Safetec

Sunscreen

Lotion

SPF 30

PABA Free

25 Packets

3.5 g (1/8 oz.)

Reorder no. 53700

Purpose

Sunscreens

Warnings

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.

Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every two hours
  • children under 6 months: ask a doctor
  • protect from excessive heat and direct sun
Active Ingredient

Homosalate (6.0%)

Octinoxate (7.5%)

Octisalate (5.0%)

Oxybenzone (5.0%)

Inactive Ingredients (Inactive ingredients)

cetyl alcohol, ganex P-904, germaben II, petrolatum, polyoxyl 40 stearate, polysorbate 60, purified water, sorbitan monostearate, tetrasodium EDTA, titanium dioxide, xanthan gum, zenicone XX

When Using This Product (When using this product)
  • keep out of eyes
  • rinse with water to remove
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a poison control center right away

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:47.048094 · Updated: 2026-03-14T23:02:30.868416